. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/EEC/405 
4 October 2011  
 (11-4785) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  European Commission 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
European Commission 
EU-TBT Enquiry Point Fax:  +(32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu  
Website:  http://ec.europa.eu/enterprise/tbt/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Medical devices 
manufactured utilising tissues of animal origin 
5. Title, number of pages and language(s) of the notified document:  Draft Commission 
Regulation concerning particular  requirements as regards th e requirements laid down in 
Council Directives 90/385/EEC and 93/42/EEC with  respect to active implantable medical 
devices and medical devices manufactured utilising  tissues of animal origin (14 pages, in 
English)  
6. Description of content:  The draft Regulation shall replace existing requirements regarding 
medical devices manuf actured utilising tissues originating of bovine, ovine or caprine species, 
deer, elk, mink or cats (i.e. TSE-susceptible species). It shall extend the scope of the current 
requirements (Directive 2003/32/EC ) to active implantable medical devices. The text sets out 
the aspects to be taken into account by manuf acturers during their risk analysis and risk 
management in order to minimise the risk of tr ansmitting animal spongiform 
encephalopathies to patients or other persons  via medical devices. The text also makes 
provision for the aspects to be taken into acc ount by designated conformity assessment bodies 
(i.e. Notified Bodies) in the context of the conformity assessment procedure.   
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Maintaining a high level of safety and health pr otection against the risk of transmitting animal 
spongiform encephalopathies to patients or other persons vi a medical devices.  G/TBT/N/EEC/405 
Page 2  
 
  8. Relevant documents:    
- Council Directive 90/385/EEC  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=CELEX:31990L0385:EN:HTML   
- Council Directive 93/42/EEC 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=CELEX:31993L0042:EN:HTML   
- Commission Directive 2003/32/EC  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2005:006:0010:0010:EN:PDF  
9. Proposed date of adoption:   
Proposed date of entry into force:    April 2012. Date of applic ation: one year later. 
10. Final date for comments:  60 days from date of notification. 
11. Text available from:  National enquiry point [  ], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
European Commission 
EU-TBT Enquiry Point Fax:  +(32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu  
The text is available on the EU-TBT Website:  http://ec.europa.eu/enterprise/tbt/  
http://members.wto.org/crnatt achments/2011/tbt/EEC/11_3197_00_e.pdf